EZ IV Administration Set
FDA 510(k) K251814 · Epic Medical Pte. , Ltd.
510(k) numberK251814
Submission
- Device name
- EZ IV Administration Set
- Applicant
- Epic Medical Pte. , Ltd.
Singapore, SG - Received
- June 13, 2025
- Decision date
- August 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | Icu Medical, Inc. | 06/05/2025SE |
More from Icu Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | 06/12/2026SE |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series)MEB · Traditional | 04/24/2026SE |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140)ONB · Special | 12/05/2025SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | 08/01/2025SE |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370)ONB · Special | 05/29/2025SE |
| K243976 | ZeroClear Bag Access (423100)ONB · Special | 01/22/2025SE |
| K240517 | ProSeal Vented Universal Vial AdaptorONB · Traditional | 12/26/2024SE |
| K241988 | ProSeal Closed System Bag AccessONB · Traditional | 10/23/2024SE |
| K241735 | ProSeal In Line Pump Set (423850)ONB · Special | 10/10/2024SE |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)MEB · Special | 10/07/2024SE |
Questions and answers
When was EZ IV Administration Set cleared by the FDA?
EZ IV Administration Set (K251814) received a 510(k) decision of Substantially Equivalent on August 29, 2025, 77 days after the submission was received.
What is the product code of K251814?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.